Through the study, patients will be trained to use the HemoScreen system to perform the 5-part Complete Blood Count (CBC) test required to manage patients' oncology therapy treatments and support clinical decision making. Healthcare professionals rely on readings including total white blood cell count, absolute neutrophil count, hemoglobin and platelet levels to make determinations for patients' treatment plans. HemoScreen allows the CBC testing process to take place within six minutes, providing results for 20 standard CBC parameters. The goal will be to enable patients to safely and routinely test their blood levels at home.

Though HemoScreen is CE-marked and FDA-cleared for POC use, it is not yet approved for home-use, though it will be used this way in a research capacity through this study.

"We needed a simple, intuitive and portable device that was easy to operate, and could provide both rapid and accurate results," said Ditte Luise Hartvig, project manager at the Department of Research Projects and Clinical Optimization at Zealand University Hospital. "HemoScreen fulfilled these criteria and offered the sophisticated CBC analysis required to meet the monitoring needs of clinicians, and also met the ease-of-use and portability criteria for our patients to participate in this study from their homes."

The study, led by the Department for Research Projects and Clinical Optimization at Zealand University Hospital, will include three phases:

Phase 1 (to be completed May 2020): HemoScreen is currently being tested within the hospital's clinical biochemical department, where researchers have been performing validation assessments on measurement accuracy as well as the system's usability.

Phase 2(to be completed by September 2020): The hospital's clinical oncological department staff will be trained, and additional usability testing will be performed for the HemoScreen system. Then, patients will be trained on using HemoScreen to ensure safe use of the capillary self-testing by patients before initiating phase 3.

Phase 3 (to be completed by December 2021): Researchers will assess the feasibility for oncology patients receiving chemotherapy to utilize HemoScreen to perform the CBC monitoring assessment from home.

HemoScreen simplifies blood testing. It uses a disposable cartridge that includes all necessary reagents and requires no maintenance or calibration. HemoScreen's underlying technology, Viscoelastic Focusing (VEF), is a patent-protected physical phenomenon that causes cells to perfectly align into a single cell layer, facilitating their rapid analysis.

"HemoScreen could save precious time for patients and healthcare systems. Currently, ill patients must travel to clinical centers for blood tests, not knowing if they are ready for treatment, spending hours waiting for their CBC result, only to be told that they aren't ready yet," said Niels Henrik Holländer, MD, Leader of Changing Cancer Care, Department of Clinical Oncology at Zealand University Hospital in Næstved. "With HemoScreen, we can potentially save patients significant time and energy exertion when undergoing these serious treatments, and also save time and costs for hospitals."

"Patients receiving oncology therapies are immunocompromised and susceptible to infection," explained Dr. Avishay Bransky, CEO of PixCell Medical. "A hospital environment presents a major risk, due to potential contact with other patients, staff and for hospital acquired infection. As such, we believe that enabling the shift to home care settings for oncology, in particular, is a crucial evolution in cancer care. Giving patients the ability to use HemoScreen for CBC at home could be the next revolutionary evolution enabling at-home oncology treatment."

PixCell Medical is supported by the European Union's research and innovation program. Changing Cancer Care is financed by the European Regional Development Fund.

About PixCell MedicalPixCell Medical provides the only simple-to-use and portable point-of-care blood diagnostic solution. PixCell's FDA-cleared and CE-marked HemoScreen™ platform shortens diagnostic results delivery from days to minutes. With just one drop of blood and within six minutes, PixCell delivers accurate readings of 20 standard blood count parameters, with the high clinical sensitivity of central lab results, saving patients, clinicians and health systems significant time and costs. PixCell leverages patented Viscoelastic Focusing technology, along with AI-powered machine vision, to deliver rapid point-of-care diagnostic results anywhere.

About Changing Cancer CareChanging Cancer Care is an EU Interreg Deutschland-Danmark project. The goal of Interreg is to promote collaboration across borders within the European Union. This is a central element in Changing Cancer Care and with the collaborating project partners coming from both Denmark and Germany, it will result in useful improvements for the healthcare system in both countries. By recruiting patients from both sides of the Danish-German border for quality development, technology research and cancer research in general, the patient pool will be much larger compared to only working on one side of the border. This means that new solutions can be tested more quickly and more effectively.